As a regulatory professional, confidence comes from having the answers you need. But what do you do when the answers just aren't there? 2014 RAPS will give you the know-how to tackle your toughest issues.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
AVIAN LLC is looking for a Compliance Specialist/Human Research Protection/Editor/Writer in Human Research Protection, to support the Human Research Protection Program at the Office of Naval Research in Arlington VA.
Experience conducting headquarters level reviews for human research studies and supporting site visits/inspections related to human research protection.
Experience in writing and editing articles as well as technical studies in areas such as human-research protection documentation for DoD/DON Assurance applications is highly desirable.
Familiarity with the DON Human Research Protection Program and the Office of Naval Research are desirable, but not required.
At least five years’ work experience in human research protection, e.g. working in an IRB office, working in a research administration office.
Experience applying human research regulations (e.g. 45 CFR 46, 21 CFR, etc.) in medical and non-medical (i.e. social behavioral research) research.
At least ten years of experience writing and editing articles as well as technical studies in areas such as human-research policy news, trends and human-systems integration.
We are a defense contracting company based in Southern Maryland that is redefining what it means to be resourceful, responsive and reachable for our customers. AVIAN LLC is a service-disabled, veteran-owned small business. We believe talent and passion generate solutions to today’s business challenges. We understand that these characteristics thrive in a business culture that embraces innovation, ...creativity and the entrepreneurial spirit.
AVIAN is headquartered in Lexington Park, Maryland with more than 190 employees located across the county. Specifically, we are supporting customers in Huntsville, Alabama; China Lake and San Francisco, California; Panama City, Florida; Lexington Park and Patuxent River, Maryland; Arlington and Quantico, Virginia.
AVIAN provides a broad range of niche expertise to more than 20 Naval Air Systems Command (NAVAIR) program offices and a total of ten prime contracts with NAVAIR, Naval Sea Systems Command and the Office of Naval Research.